TAG Issue Brief: Suboptimal Immune Recovery on Antiretroviral TherapyMarch 5, 2018 - Antitretroviral therapy is highly effective at suppressing HIV viral load, but for some individuals this does not lead to adequate reconstitution of the immune system. TAG's issue brief offers an overview of suboptimal immune recovery on antiretroviral therapy, and explains why it remains an important concern.

Ending the HIV/AIDS EpidemicDecember 26, 2017 – We now have evidence-based tools for HIV treatment and prevention that are so effective that they could conceivably end the most deadly infectious disease epidemic in modern history. Many community leaders across the United States are calling for just that: an end to the HIV/AIDS epidemic in their cities, their counties, and their states.

TAGline Fall 2017NEWS ON THE FIGHT TO END HIV/AIDS, VIRAL HEPATITIS, AND TUBERCULOSIS

Community Calls On United Healthcare to End Discriminatory Prior Authorization Practices for PrEP AccessAugust 4, 2017 - 14 organizations, along with TAG, sent a community letter to United Healthcare (UHC) calling on the insurer to end discriminatory practices in regards to patient access for Pre-exposure Prophylaxis (PrEP) for HIV prevention. Specifically, UHC has been requiring documentation for prior authorization every three months for Truvada, prescribed for PrEP. Advocates cite such practices as a violation of the Affordable Care Act's non-discrimination policies and a barrier to accessing a vitally important prevention tool for vulnerable communities. Furthermore, denial letters that are being sent contain inappropriate and judgemental language that questions UHC members' sexual orientation, HIV status and/or drug use, which only continues to perpetuate stigma and discrimination.

Sign-on Letter in Response to Critical Shortage of Penicillin for Syphilis Treatment in U.S.June 22, 2017 – A sign-on letter urging Pfizer to adequately and promptly address the penicillin G benzathine (Bicillin-LA) shortage to ensure normal quantities in the United States. Bicillin-LA remains the preferred treatment for primary and secondary syphilis in adults, infants, and children, and the only approved treatment for syphilis in pregnant women. As the only manufacturer of pencillin G benzathine in the United States, Pfizer’s inability to provide adequate quantities of Bicillin-LA has left the Food and Drug Administration, the Centers for Disease Control and Prevention, and many city and state health departments scrambling to ration existing stockpiles of the drug and develop contingency plans.

The New War on DrugsThe 21st Century Cures Act and a right-wing war on regulations are direct threats to FDA evidentiary requirements for drugs, biologics, and devicesBy Tim Horn and Suraj Madoori

HIV Activist Learning Modules: Engaging our Community in HIV Prevention Policy AdvocacyMarch 29, 2017 – To support the efforts of prevention advocates across the United States, TAG's HIV Project has developed a series of modules to help support activists’ capacity needs and to develop advocacy action plans. The slides, handouts, and webinars in each of the four modules focus on how to identify and change the governmental, organizational, and institutional policies that create roadblocks to comprehensive HIV prevention in our communities. The materials are useful for personal education or group discussion on HIV prevention and policy advocacy.

Community Survey on PrEP and Biomedical Prevention Clinical TrialsMarch 7, 2017 – TAG is interested in learning more about activist and community leader perspectives on the provision of Truvada for pre-exposure prophylaxis (PrEP) in clinical trials of biomedical prevention interventions (e.g. HIV vaccines, antibody or immune-based prevention interventions, and other forms of antiviral PrEP). Please consider completing our questionnaire by March 20th.

Shortage of Injectable Estrogen a Crisis for Transgender WomenPublic health experts call on FDA to better manage drug shortage process.December 5, 2016―Today, The Fenway Institute of Fenway Health, Callen-Lorde Community Health Center, and Treatment Action Group (TAG) released a policy brief documenting the public health emergency created by a shortage of injectable estrogen, and calling on the U.S. Food and Drug Administration (FDA) to be more proactive in resolving the crisis.

HIV Activists Seek to Accelerate Development of Immune Enhancing Therapies for Immunologic Non-RespondersDialogues with FDA, scientists and industry encourage consideration of orphan drug designations for therapies to help the immunologic non-responder population and exploration of novel endpoints to reduce the size of efficacy trials.November 30, 2016 – A coalition of HIV/AIDS activists are calling for renewed attention to HIV-positive people termed immunologic non-responders (INRs), who experience suboptimal immune system reconstitution despite years of viral load suppression by antiretroviral therapy. Studies have shown that INR patients remain at increased risk of illness and death compared to HIV-positive people who have better restoration of immune function on current drug therapies. Risk factors for becoming an INR include older age and a low CD4 count at the time of treatment initiation. To date, efforts to develop immune enhancing interventions for this population have proven challenging, despite some candidates from small companies showing signs of promise.

TAGline Fall 2016NEWS ON THE FIGHT TO END HIV/AIDS, VIRAL HEPATITIS, AND TUBERCULOSIS

Toward Health EquityWe will not end HIV as an epidemic without the expertise and leadership of Black and Latino gay and bisexual men and transgender people of color.By Jeremiah Johnson

#FairDrugPricesNowSeptember 28, 2016 – Treatment Action Group, in conjunction with the Human Rights Campaign (HRC) and the Fair Pricing Coalition Launch #FairDrugPricesNow Campaign, a new effort to organize the LGBTQ community around common-sense solutions to drug pricing and price increasing.

Greed and the Necessity for RegulationThe story of U.S. drug pricing run amok isn’t just about corporate arrogance and avarice—it is also about government permissiveness and inactionBy Tim Horn, Erica Lessem, and Kenyon Farrow

PrEP Pricing Problems A number of barriers to pre-exposure prophylaxis (PrEP) uptake, use, and adherence have been identified—cost shouldn’t be one of themBy James Krellenstein and Jeremiah Johnson

The Low Cost of Universal AccessGeneric treatments for HIV, viral hepatitis, and cancer can be affordably—and profitably—mass-produced for broad, unobstructed availabilityBy Tracy Swan

HIV Community Letter to Hillary for AmericaMarch 14, 2016 – Dear Secretary Clinton: We write to you in the sincere hope that we can work together to transform the pain caused by your March 11th mischaracterization of the Reagans’ role in the AIDS crisis into an urgently needed public discussion of a plan to end the United States HIV epidemic by the year 2025.

Treatment Action Group hails Governor Cuomo’s proposed legislation allowing minors to maintain confidentiality when obtaining HIV treatment or preventive therapyFebruary 11, 2016 – "Governor Cuomo continues to provide globally unprecedented leadership with New York State's plan to end AIDS as an epidemic by the year 2020,” said Treatment Action Group executive director Mark Harrington. “With today's announcement that he will submit legislation allowing minors to consent to receive antiretroviral therapy (ART) or pre-exposure prophylaxis (PrEP) to treat or prevent HIV infection, New York State moves closer to achieving an AIDS-free generation in this decade. Treatment Action Group salutes the governor's sustained leadership in these efforts and calls on state legislators to rapidly and unanimously pass this lifesaving, infection-averting legislation to end AIDS and HIV acquisition among our state's youth."

TAG's Response to Senator Cassidy's Statements on AIDS Research SpendingNovember 19, 2015 – I would like to offer comments to correct the record on statements given by Senator Bill Cassidy (R-LA) at the October 7, 2015, hearing on the National Institutes of Health fiscal year 2016 budget. Several of his comments to the committee and NIH Director Francis Collins were incorrect or misleading. If his erroneous statements about AIDS research funding at the NIH are mistaken for fact, we will set a dangerous course for current and future research being conducted at the agency and undermine the prioritization process under way at the Office of AIDS Research (OAR).

ACT UP\New York and TAG to Host Town Hall Meeting to Discuss Drastic Cuts to City’s HIV Testing and STD Screening ProgramsAugust 31, 2015, New York, New York – In response to disturbing trends in New York City’s response to the ongoing HIV and STD epidemics, ACT UP/New York and Treatment Action Group (TAG) will host a town hall meeting at the New York City LGBT Center on 13th Street in Manhattan at 6:30 PM on September 1, 2015. ACT UP and TAG seek to push the de Blasio administration to mitigate the massive citywide reduction of sexual health services in recent years, including the March 2015 closure of the Chelsea STD Clinic.

Toward Comprehensive HIV Prevention Service Delivery in the United States: An Action PlanJune 24, 2015 – An objective of the National HIV/AIDS Strategy (NHAS), released by the White House in July 2010, is to lower the annual number of new infections in the United States by 25 percent by the end of 2015. Yet it is unclear if we will succeed in meeting this arguably unambitious target: 36,400 estimated new infections in 2015, compared with the 48,600 new infections estimated for the baseline year of 2006.

Governor Releases Blueprint to End AIDS in NYS by 2020April 29, 2015 – New York, NY– Governor Cuomo formally accepted the long-awaited Blueprint to End AIDS at a public event on Wednesday, marking an important step towards fulfilling his commitment to end AIDS in New York State.

Governor Cuomo’s Ending the Epidemic Task Force Completes Plan to End AIDS in NY State by 2020– Activists, service providers, public health professionals hail governor’s leadership, call on legislators and local governments to join forces to end the epidemic – January 13, 2015, Albany, New York – Today the Ending the Epidemic Task Force, convened by the New York State Department of Health (DOH) at the behest of Governor Andrew M. Cuomo, completed its comprehensive, rigorous, and unprecedented Plan to End AIDS in New York State by 2020.

Advocates Urge Governor Cuomo to Withdraw Mandatory Quarantine OrderOctober 26, 2014 – We write as professionals, activists, and public health researchers who have worked to combat AIDS and other infectious diseases in New York and around the world for over three decades. We have not forgotten how HIV/AIDS was at first largely ignored while it appeared to affect only marginalized communities or the stigma generated once fear of the virus took hold in the larger population. We have watched with growing concern as Ebola virus disease (EVD) was ignored far too long while confined to some of the poorest countries in the world, and how it has now led to hysteria here in the United States, based on only a very small number of cases. As you know, stigma remains our biggest enemy in fighting AIDS and could quickly become the biggest barrier in combatting EVD. Therefore, we implore you to withdraw the mandatory quarantine requirement for all people entering the United States through Newark Liberty International Airport and John F. Kennedy International Airport who have had direct contact with individuals with EVD in Guinea, Liberia, and Sierra Leone.

NYS Ending Epidemic Task ForceOctober 14, 2014, New York, New York – Treatment Action Group (TAG) welcomes today’s announcement by the New York State Department of Health (DOH) of the Ending the Epidemic Task Force to more fully develop Governor Andrew Cuomo’s Plan to End AIDS as an epidemic in New York State by the year 2020.

Treatment Action Group Commends Governor Cuomo for Launching Historic New York State Plan to End AIDSTAG Calls on Governor to Expeditiously Appoint a High-Level Task Force to Develop Blueprint to End AIDS Deaths and Halt New HIV InfectionsJune 29, 2014, New York, New York – Treatment Action Group (TAG) applauds Governor Andrew M. Cuomo for his full support of a historic community-developed plan to end the AIDS epidemic in New York State by 2020, as announced this morning by the Governor’s office and reported in today’s edition of the New York Times (“Cuomo Plan Seeks to End New York’s AIDS Epidemic,” Anemona Hartocollis, page A18). With this bold initiative, New York State—long the epicenter of the nation’s HIV epidemic—becomes the first jurisdiction anywhere in the world to publicly declare a goal of ending AIDS as an epidemic with the launch of a comprehensive effort to end AIDS deaths and halt new infections by employing state-of-the-art testing, preventive technologies, treatment, and supportive services.

ACT UP to Tom Frieden: You’re MIA on HIVNew Infections on the Rise in Key Subpopulations, Despite Options for PreventionJune 9, 2014 – Members of ACT UP NY, along with Treatment Action Group (TAG) and Atlanta allies, will meet with the Centers for Disease Control & Prevention (CDC)’s HIV prevention personnel in Atlanta, GA. ACT UP will call upon the CDC to meet its commitment of keeping all Americans healthy and to act now upon the promise of TasP, PrEP, and PEP, address social and structural barriers to lifesaving prevention options, and reduce the transmission of HIV in those groups where the incidence is rising.

Research Toward a CureMarch 27, 2014 – A listing of clinical trials and observational studies related to the research effort to cure HIV infection, mainly derived from the clinicaltrials.gov online registry. Click the identifier numbers for a link to the full clinicaltrials.gov entry containing detailed information on the trial design, enrollment criteria, principal investigators and location(s). It's important to appreciate that at the current time, none of these studies is expected to produce a cure for HIV infection—they represent research working toward that goal. Table 3 contains completed studies, with links to published or presented results where available.

Filling the Gaps in the U.S. HIV Treatment Cascade: Developing a Community-Driven Research AgendaDecember 1, 2013 – TAG and amfAR sponsored a workshop in Washington, D.C., on June 18–19, 2013, to develop a community-based agenda to improve implementation of effective service-delivery approaches and identify research priorities for improved management of HIV treatment and prevention, with a particular focus on filling the gaps in the United States HIV continuum of care (or treatment cascade). This document represents the outcomes from that meeting, attended by representatives from government, academia, and health care systems, along with community-based advocates and service providers.

167 Organizations and 513 Individuals Signed on to Letter to Secretary Sebelius on the Allowance of Co-pay Assistance in the ACA Health PlansDecember 2, 2013 – We, the undersigned organizations and individuals, are writing to urge that the HHS issue clear guidance on the allowance of drug industry–provided co-payment, co-insurance, or other out-of-pocket discount cards and coupons in the Affordable Care Act’s (ACA) Health Insurance Marketplaces. As people living with, and organizations serving people with, HIV, HCV, and other life-threatening and chronic health conditions, we are alarmed by the possibility of the prohibition of these critical financial lifelines in the ACA, just as affordable health insurance for people with preexisting conditions is finally becoming a reality in the United States, thanks to the ACA.

amfAR/TAG Issue Brief: The Cost of Flat Funding for Biomedical ResearchAugust 12, 2013 – “The Costs of Flat Funding for Biomedical Research,” prepared by the Foundation for AIDS Research (amfAR) in collaboration with TAG, examines the declining purchasing value of public funding for health research at the National Institutes of Health (NIH) and the impact this has on public health, scientific progress, US productivity, and US science leadership.

Preexposure Prophylaxis (PrEP) Trial among Thai Injection Drug Users Marred by Lack of Response to Community ConcernsJune 26, 2013 – On June 12, results from an efficacy trial of tenofovir as pre-exposure prophylaxis (PrEP) against HIV infection in individuals with a self-reported history of injection drug use were published in the Lancet. The trial was sponsored by the U.S. Centers for Disease Control and Prevention (CDC) and took place in Bangkok, Thailand (named the Bangkok Tenofovir Study). The publication was accompanied by a flurry of press releases and drew considerable news coverage due to the documentation of a statistically significant reduction in risk of HIV acquisition of 48.9%.

Letter to Gilead - Tenefovir Alafenamide Fumarate (TAF) (Final with 293 signatories)June 24, 2013 – With a phase II clinical trial of tenofovir alafenamide fumarate (TAF) yielding encouraging preliminary results and regulatory planning for TAF-inclusive fixed-dose combinations (FDCs) under way, we are compelled to reach out to you regarding the need for a stand-alone formulation of the drug.

The Immune System, HIV, and AgingJune 3, 2013 – Little more than a decade ago, it was almost inconceivable that the issue of aging with HIV infection would emerge as an important concern. But it has now become clear that combination antiretroviral therapy (ART) can suppress virus replication for many years—likely for life—in most people who can access the drugs, and the opportunistic infections that were once the primary causes of illness have largely evanesced everywhere treatment is available. Morbidity and mortality from HIV infection has plummeted, and the survival of HIV-positive individuals is edging ever closer to that of comparable HIV-negative people. With the specter of AIDS having finally been chased from the near horizon, attention has turned to health problems that may lie further down the road.

Revitalizing the U.S. National HIV/AIDS StrategyMeeting Report and Action PlanApril 15, 2013 – On December 11–12, 2012, in Washington, D.C., Treatment Action Group (TAG) hosted a meeting of HIV advocates, service providers, and researchers from across the United States (U.S.) to review the current state of the national HIV response and discuss how to revitalize the National HIV/AIDS Strategy (NHAS). Meeting participants reviewed the latest data, discussed the changing landscape of the HIV response, and developed recommendations for continued and expedited progress. The Meeting Report summarizes the presentations and discussions, and outlines the key recommendations from participants. The Action Plan incorporates the recommendations from the meeting report.

March 6, 2013 – Advances in HIV treatment research in 2010 and 2011 saw improvement in treatment regimens and strategies, and reinvigorated optimism for finding a cure. In 2012, TAG and AVAC, with financial support from UNAIDS, put forth a collaborative effort to analyze investment trends in HIV treatment research and development (R&D) in 2010 and 2011.

Micardis Sign-On Letter to Boehringer IngelheimNovember 30, 2012 – Dear Dr. Piliero: We, the undersigned organizations and individuals, urge Boehringer Ingelheim Pharmaceuticals to reconsider its negative decision to provide free telmisartan (Micardis) and matching placebo to the AIDS Clinical Trials Group so that it may move forward with Study A5317, a multicenter trial evaluating the effects of telmisartan on fibrotic and inflammatory contributors to end-organ disease in HIV-infected patients well controlled on antiretroviral therapy.

Letter Opposing a Proposed Low-Dose Stavudine TrialDecember 14, 2011Dear Mr. and Mrs. Gates, We write as people with HIV and community activists with serious and unresolved concerns about the proposed clinical trial comparing stavudine at 20 mg to tenofovir. Although we are broadly very supportive of dose optimisation strategies, we do not support this trial; we do not think that the Bill and Melinda Gates Foundation should support it; nor do we think it should proceed. Several of us have discussed this with your representatives both formally and informally over the past months. Those of us who met with your representatives on 19 July 2011 at the International AIDS Society conference in Rome received no response to the concerns we raised. We summarise our objections as follows:

October 2011 – The meeting, sponsored by the AIDS Policy Project, amfAR, Project Inform, and TAG, featured an overview of HIV latency, persistence, and eradication research; lessons from past clinical trials; a review of current or impending trials; and a full discussion of issues including trial design, appropriate markers and endpoints, and development of better assays. Participants heard a presentation on the ethics of clinical trials and discussed the federal regulatory process and how best to engage the several branches of the U.S. Food and Drug Administration (FDA) in a coordinated and collaborative way to work together to ensure that cure-related clinical trials proceed expeditiously, ethically, and safely.

September 2011 – As this i-Base and TAG 2011 Pipeline Report, Second Edition, makes clear, medically, the prospect for people with HIV, hepatitis C virus (HCV), and tuberculosis (TB) to live long and healthy lives—and in the cases of HCV and TB, to be cured rapidly with safe, effective, oral combination therapy—has never been better.

July 2011 – The HIV treatment research landscape is changing. Thanks to recent treatment scale-up and prevention science breakthroughs and the new global treatment target of 15 million by 2015, there is real momentum to bring the epidemic under control and ultimately end it. To capitalize on these scientific gains, continued investment and innovation are necessary to prevent new infections, to ensure people currently on treatment are able to continue, and to scale up treatment to reach all those who will benefit from earlier initiation of antiretroviral therapy. This report from TAG, UNAIDS, and the AIDS Vaccine Advocacy Coalition documents $2.46 billion in HIV-related research investments.